Cristofoli 127 V Manuel utilisateur

Cristófoli Distiller

Cristófoli, Brazilian company importer and manufacturer of

health products certified by ISO 9001 - Quality Management

System, ISO 13485 - Medical Devices - Quality Management

System - Requirements for Regulatory Purposes, ISO 14001-

Environmental Management and *BPF - Boas Práticas de

Fabricação - ANVISA.

13485

CRISTÓFOLI’S MISSION

CRISTÓFOLI’S QUALITY AND ENVIRONMENTAL POLICY

Develop innovative solutions to protect life and promote health.

Cristófoli Equipamentos de Biossegurança Ltda., established at Rodovia BR-158, nº 127,

Jardim Curitiba in Campo Mourão, Paraná, Brasil, manufactures biosafety equipment to assist

the health field having as policy: “Develop innovative solutions for the health field by using

agile, robust and objective processes to better serve its clients. Fulfill the requirements for

regulatory purposes of the applicable standards, promote the continuous improvement of its

quality and environmental systems, prevent pollution, reduce its environmental impacts and

continuous training of its employees, achieving this way, a sustainable profitability and the

maximization of the company’s value”. Rev. 2.

*BPF - Boas Práticas de Fabricação:

Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US).

Destilador Cristófoli Inglês Rev.1-2015

TABLE OF CONTENTS

Legend of Symbols ...........................................................................................................

Intended Use ....................................................................................................................

Contents of the Box ..........................................................................................................

Recommendations and Warnings ....................................................................................

Installation Instructions ......................................................................................................

Safety Devices ..................................................................................................................

Components Identification ...............................................................................................

How to Use the Cristófoli Distiller ........................................................................................

Distilled Water for Human Consumption ...........................................................................

Water for steam sterilization ..............................................................................................

Distilled Water Shelf Life and Storage ................................................................................

How to Identify your Distiller ...............................................................................................

Technical Data .................................................................................................................

Preventive Maintenance ...................................................................................................

Troubleshooting ................................................................................................................

Quality control ..................................................................................................................

Authorized Technical Assistance .......................................................................................

Customer Service Department - CSD ...............................................................................

Guidance for Final Disposal of the Equipment .................................................................

Warranty Terms ..................................................................................................................

C R I S T Ó F O L I

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LEGEND OF SYMBOLS

This Side Up

Maximum Pile

Caution, consult

accompanying

documents

Manufacturer

Alternate Current

Date of

Manufacture

* Boas Práticas

de Fabricação

LOT

Fragile

Handle with Care

Serial Number

Batch Number

Keep Away from

Sunlight

Recyclable

Keep Dry

ISO 13485

ISO 14001

ISO 9001

13485

C R I S T Ó F O L I

D I S T I L L E R

I N S T R U C T I O N M A N U A L

Responsible Technician

Eder William Costa Camacho

CREA/PR – 87826/D

MANUFACTURER

Cristófoli Equipamentos de Biossegurança Ltda.

Rod. BR 158, nº127 - Campo Mourão - PR - Brasil

CEP 87309-650

CNPJ 01.177.248/0001-95 - Inscr. Est. 90104860-65

Website: www.cristofoli.com - e-mail: [email protected]

Items included in the product box:

- - 1 Cristófoli Distiller; 1 heating element filter;

- 1 metal clip; - 3 activated carbon filters;

- 1 cap for the distilled water container; - 1 instruction manual.

CONTENTS OF THE BOX

This equipment was developed to distill water to be used in steam sterilization autoclaves or

any other application where it is necessary to use distilled water.

INTENDED USE

RECOMMENDATIONS AND WARNINGS

Read all the instructions in this manual before using your distiller. Incorrect use may result in

damage to the equipment and/or accidents.

The equipment must be handled by qualified and well-informed personnel, regarding its

features and functioning.

For your safety, when performing any kind of maintenance, remember to unplug the

equipment and use PPE (Personal Protective Equipment).

Make sure all the air openings for ventilation on the top of the distiller and on its sides are not

obstructed.

As a routine, make sure all the distiller components are properly fitted before using it. Non-

observance of this procedure may interfere in its correct functioning. See “How to Use the

Cristófoli Distiller” (Page 7).

Never remove the main unit or touch the water tray while the distiller is on;

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INSTALLATION INSTRUCTIONS

The storage must be done in a place protected from the weather action (indoors) in

normal temperature conditions

Install the distiller in an exclusive sterilization room, ventilated and clean, on a flat, leveled

and firm surface, . at a proper height for the operator to handle it Leave enough room next to

the distiller for handling the water containers.

ELECTRICAL

See “Authorized Technical Assistance” (Page 12). In case the user chooses an

unauthorized electrician or technician to install the equipment, Cristófoli Biossegurança will

not be responsible for any services performed in disagreement with the instructions

described in the product manual.

The voltage of the distiller is 127V or 220V, as informed on the identification label

locat Make sure the wiring where the ed on the bottom of the equipment. voltage

equipment will be installed is in accordance with these values.

For the installation, use a three pin outlet with grounding pin (2P + T, 10A).

Never use extensions, adapters or voltage transformers.

ATTENTION Grounding is very important for the safety of the operator and the warranty of !

your equipment. Install the distiller where it can be easily unplugged.

The electrical installation must follow the data from the table below.

Table 1

MODEL AMPERAGE WIRING GAUGE (DIAMETER)

Cristófoli Distiller

(127 V)

4,3 A

Cristófoli Distiller

(220 V)

The wiring from the breaker to the electrical outlet

used to connect the equipment

must have a diameter of at least 2.5 mm.

2,2 A

INSTALLATION OF THE HEATING ELEMENT FILTER

The function of the filter is to reduce scales (mineral deposits)

build up on the heating element during the distillation process The .

majority of the mineral deposits will adhere to the filter which can be

washed and reused This . See “Preventive Maintenance” (Page 10).

ensures maximum heating efficiency and performance of the

distiller.

A. Remove the filter from the plastic bag and soak it in water;

B. Remove the main unit, turn it upside down, install the filter over

the heating element (Fig. 1) and use the metal clip provided to

hold it in place (Fig. 2). Put the main unit back in its original

position.

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Fig. 1

Fig. 2

SAFETY DEVICES

THERMOSTAT - Internal device of the equipment, its function is to prevent an overheating of

the heating element.

THERMAL FUSE - Internal safety device that cuts the electrical current of the equipment, in

case the thermostat malfunction. There are two thermal fuses, one attached to the heating

element and another in the motor.

WATER LEVEL SWITCH - Device (Fig. 4, page 7) which function is to turn the equipment off in the

following cases:

A. If the tap water container is removed, tilted or raised.

B. At the end of the distillation cycle.

Note.: All components in direct contact with the water are non-toxic.

COMPONENTS IDENTIFICATION

Fig. 3

Main Unit

On/Off Switch

Indicative

LED

Water Tray

Tap Water Container

Cap

(with spring valve) Activated

Carbon Filter

Distilled

Water

Container

Base Unit

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Fig. 4

Water Level Switch

Power Cable

Heating

Element

Filter

1. . Make sure the distilled water container is fitted on the base unit, without the cap

2. ( Take the tap water container, remove its cap and fill it up with regular tap water potable

water provided by the public water system) or filtered water, put the cap back on the container

and fit it on the base unit. The use of filtered water reduces the formation of scales (mineral

crusts) on the heating element and makes maintenance easier.

3. Allow at least one minute so the water fills the tray. Plug the distiller into the electric outlet and

press “ON-Reset” on the on/off switch. At this moment, if the indicative LED is on, it means that

one of the following situations is happening:

The tap water container is not properly fitted on the base unit, adjust it;A.

The water tray is not completely filled with water. Switch it to “OFF”, wait for the indicative B.

LED to go out and switch back to the“ON-Reset” position.

4. When the cooler starts, the distiller will initiate heating. It will take from 3 to 5 minutes for the

distiller to begin producing distilled water.

5. When the tap water container empties out, the distiller will shut off automatically and the

indicative LED will be lit.

6. After the distiller shuts off, press “OFF” on the “ON/OFF Switch” .

7. At the end of the day, unplug the equipment.

Note: In case a power outage occurs, the distiller will have to be reset to continue operation

when energy is restored. To reset the distiller, press “OFF” on the “OFF/ON-Reset” switch, wait for

about 3 seconds until the indicative LED turns off, then, press “ON-Reset”;

HOW TO USE THE CRISTÓFOLI DISTILLER

C R I S T Ó F O L I

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When indicated for human consumption, consider that distilled water loses minerals during

the distillation process. Follow the procedure below:

Carry out the first two cycles without the activated carbon filter and discard the water or A.

use it in steam sterilization autoclaves, air humidifiers, etc. When the distiller is used for the

first time, there can be some remaining harmless matter from manufacturing, packing or

shipping that could alter the taste of the water.

Before proceeding with the third cycle, clean the distilled water container, the tap water B.

container and the water tray with water and neutral soap, rinse them well.

C. Get the carbon filter from the plastic bag and soak it in water for 30 seconds to rinse

away any loose small particles of carbon and put it on the distilled water container

opening, just like a cap and start the third distillation cycle. When the cycle is complete,

remove the carbon filter, let it dry naturally and put it back into the plastic bag until you

need it again.

DISTILLED WATER FOR HUMAN CONSUMPTION

Table 2

Follows below the “Table C.1 - from the Standard Contaminants of Feed Water”

13060:2009, Annex C (Informative) with the suggested values for the water to be used in steam

sterilization autoclaves.

In some specific cases, it may be demanded the water to be purified by special

processes. Check if the parameters obtained meet your needs.

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Evaporate residue £ 10 mg/L

Lead £ 0.05 mg/L

Conductivity (a 20 ºC) £ 15 ms/cm

Iron £ 0.2 mg/L

Chloride £ 2 mg/L

Appearance Colourless, clean, without sediment

Silicium oxide, SiO2£ 0.1 mg/L

Rest of heavy metals, excluding,

iron, cadmium, lead £ 0.1 mg/L

pH value 5 a 7.5

Cadmium £ 0.005 mg/L

Phosphate £ 0.5 mg/L

Hardness £ 0.02 mmol/L

Table C.1 — Contaminants of Feed Water

Note 1: The use of water for steam generation with contaminants at levels exceeding those given in this

table can greatly shorten the working life of a sterilizer and can invalidate the manufacturer's warranty of

guarantee.

WATER FOR STEAM STERILIZATION

The distilled water for human consumption (when indicated) and /or to be used in steam

sterilization autoclaves is 15 days from the date it was distilled.

The storage of the distilled water must be done in a clean plastic or glass container properly

closed and protected from light and heat. The storage cabinets must be easy to clean,

located in a dry room with fresh air, free from odors and away from disinfectants, sterilants

and/or humidity.

DISTILLED WATER SHELF LIFE AND STORAGE

The identification label is affixed on the bottom of the equipment.

ATTENTION - Removing the Identification Label and/or any other stickers from the product will

cause automatic loss of warranty.

HOW TO IDENTIFY YOUR DISTILLER

TECHNICAL DATA

Tap Water Container Capacity ...............................

Distilled Water Container Capacity .........................

Gross Weight (packed) ...........................................

Net Weight ..............................................................

Cycle Total Time (full Container) .............................

Equipment Dimensions (W x H x D) ..........................

Box Dimensions (L x A x P) .......................................

Voltage ...................................................................

Frequency ..............................................................

Power & Energy Consumption (model 127 V) .........

Power & Energy Consumption (model 220 V) .........

Proper Working Temperature ...................................

Certifications ...........................................................

4 liters

3,8 liters

4 kg

3,4 kg

6 a 8 hours (to distill 3,8 liters of water)

27 x 33 x 27,6 cm

30,5 x 36 x 30,5 cm

127 or 220 V ~ single-phase

50/60 Hz

550 Watts - 0,55 Kw/hours

450 Watts - 0,45 Kw/hours

15 ºC to 40 ºC

This equipment is imported by Cristófoli, company which

Quality Management System is certified and in

accordance with the ISO 9001:2008, ISO 13485:2003,

BPF- Boas Práticas de Fabricação - ANVISA (Brazilian

standard similar to GMP - FDA/US) and ISO 14001:2004 -

Environmental Management standards.

TECHNICAL DATA CHART CRISTÓFOLI DISTILLER

Table 3

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Some procedures are necessary for the best functioning and durability of your equipment.

The preventive manintenance corresponds to the fulfilment of all procedures listed below.

Make sure the distiller is unplugged and cold before touching or handling it. Wait al teast 30

minutes for cooling after unplugging the equipment.

Table 4

PREVENTIVE MAINTENANCE

PERIODICITY

MAINTENANCE

DAILY

External cleaning:

Unplug the equipment. Use a cloth dampened with biodegradable

neutral detergent, next, clean it with another cloth dampened with

alcohol 70% or peracetic acid at 1%, make smooth movements in one

direction only.

EVERY

6 CYCLES

Water tray, filter and heating element cleaning:

The water tray is removable, it can be washed manually or put into the

dishwasher.

Remove the clip and the filter, next, wash it in running water and set it

aside until you assemble the equipment again.

Fill the water tray with white vinegar, let it rest for at least 3 hours. The

cleaning solution will soften the scale deposits.

After that, remove the main unit and the water tray, wash the heating

element with a brush with soft bristles, next, wash the water tray and rinse

it. Finish the cleaning procedure with a soft cloth that does not shed.

EVERY

2 MONTHS

Activated carbon filter replacement:

Depending on the frequency of distillation cycles intended for human

consumption, the replacement may be anticipated. Additional filters

may be purchased at the Cristófoli Authorized Technical Assistance.

EVERY

3 MONTHS

Heating element filter replacement:

Depending on the quality of the water, the replacement may be

anticipated. Additional filters may be purchased at the Cristófoli

Authorized Technical Assistance.

C R I S T Ó F O L I

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